A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated NSCLC

National Cancer Centre, Singapore

Status: Enrolling

Conditions: Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06418412

ATORG006

Details and patient eligibility

About

There are limited in depth studies on the epidemiology and clinical management of EGFR exon 20 insertion mutated NSCLC in Asia. In addition, there is preliminary data suggesting the exact location of the insertion and variant may influence the response and efficacy to novel EGFR targeted therapies.

This study aims to fill this knowledge gap, by comprehensively characterising the epidemiology and clinical outcomes of Asian advanced EGFR exon 20 insertion mutated NSCLC patients.

Full description

This study will be a multi-center observational study and will enroll patients with advanced EGFR exon 20 insertion mutated NSCLC.

The study will include patients recruited from countries across Asia, including sites in, but not limited to - Hong Kong, Korea, Singapore, Taiwan and Thailand. There will be approximately 20-30 sites recruiting for the study. In Singapore, sites may include National Cancer Centre Singapore (NCCS), National University Hospital (NUH) and Tan Tock Seng Hospital (TTSH).

Approximately 600 patients will be enrolled retrospectively.

Enrollment: 600 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed advanced NSCLC
2. Positive testing result from any locally approved test (including but not limited to RT-PCR, Cobas and NGS) for EGFR exon 20 insertion mutation
3. Diagnosis date from 1 Jan 2013 to 31 Dec 2022 (to allow for minimum 12 months of follow-up clinical and treatment outcome data)
4. Male or female adults, age as defined by local regulations

Exclusion criteria

1. Patients without an EGFR exon 20 insertion mutation